In Response to Shortage, CDC, FDA Accelerate Release of RSV Shots for Infants

FRIDAY, Nov. 17, 2023 — More than 77,000 doses of Beyfortus, the long-acting monoclonal antibody designed to protect infants too young for vaccination against respiratory syncytial virus (RSV), were released Thursday by the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration in an effort to address a continuing nationwide shortage.

The doses will be distributed immediately to doctors and hospitals through the federal Vaccines for Children Program and commercial channels, the agencies said.

The CDC has also taken steps to make the shots more accessible for doctors to order through the Vaccines for Children program, which provides vaccines to half of America”s children. The CDC and FDA both said they will continue to be in close contact with manufacturers to clear the way for more doses of Beyfortus through the end of the year and into early 2024.

Shortages of Beyfortus — which is for children younger than 8 months whose mothers did not receive the adult RSV vaccine — have been plaguing the United States this cold and flu season. This is the first RSV season the drug has been available, and demand has far exceeded supply, drug maker Sanofi said late last month.

In October, the CDC recommended that Beyfortus (nirsevimab) be prioritized for infants at the highest risk for severe RSV infection. These included infants younger than 6 months and infants with underlying medical conditions that place them at higher risk for severe infection, including premature birth, lung disease, heart disease, immunocompromised conditions, and severe cystic fibrosis.

There is another RSV shot available, called Synagis (palivizumab), and the American Academy of Pediatrics has recommended that children between 8 months and 19 months receive that shot instead. Synagis must be given once a month during RSV season, so it is not as convenient to get as the Beyfortus shot.

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